MAUDE Adverse Event Report: LIMACORPORATE S.P.A SMR SHOULDER; ECCENTRICAL GLENOSPHERE DIA. 36 MM

Model Number	1376.09.031
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	05/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Revision surgery has been performed on (b)(6) 2026 due to infection.Previous surgery is unknown, as well as complete product information of original assembly.During revision, the pre-existing smr reverse humeral body (pn 1352.15.010), reverse liner +3mm (pn 1360.50.815), eccentrical glenosphere dia36mm (pn 1376.09.031) and connector (pn 1374.15.310) has been removed and replaced with new ones.An additional bone screw (pn 8420.15.010) has been added to the baseplate for better fixation.Surgery has been completed as intended.Patient is female, date of birth j(b)(6) 1964.The event occurred in the united states.
Additional Manufacturer Narrative
Explanted components have been discarded therefore are not available for identification and analysis.From followup communication it was confirmed that lot number cannot be retrieved therefore no review of manufacturing records can be performed.No information regarding patient clinical history and/or comorbidities was available, but according to sales rep the original prosthetic assembly was implanted around 15 years before.The only available pre-op xray was shared with medical expert who analysed and revealed several problems with the patient shoulder: glenoid loosening an migration, bone loss at the humeral epiphysis/metaphysis, bone formation in the deltoid, like heterotopic ossification.The latter can also be an acromion fracture treated conservatively or plastic deformation over time with bending of the acromion, but cannot be cleared without further radiographs over time.According to the whole clinical picture, the event has been assessed by medical expert as a clear infection problem with septic loosening with no sign for implant related failure.Taking into account that: - implant lasted for about 15 years, - medical expert confirmed a critical patient condition, the manufacturer has no evidence to consider the event as product related.Based on the available pms data, the revision rate of smr glenosphere, belonging to the family product codes 1374.15.Xxx, 1376.15.Xxx, 1374.09.Xxx, 1376.09.Xxx, due to infection is around 0.06%.According to the investigation carried out, no corrective action is needed for this event.The manufacturer will continue monitoring the market in order to detect any similar event.

• Brand Name: SMR SHOULDER
• Common Device Name: ECCENTRICAL GLENOSPHERE DIA. 36 MM
• Manufacturer (Section D): LIMACORPORATE S.P.A; via nazionale 52; villanova di san daniele, udine 33038 ; IT 33038
• Manufacturer Contact: via nazionale 52; villanova di san daniele, udine 33038
• MDR Report Key: 25680183
• Report Number: 3008021110-2026-00254
• Device Sequence Number: 4707651
• Product Code: PHX
• UDI-Device Identifier: 08033390272339
• UDI-Public: 8033390272339
• Combination Product (Y/N): N
• PMA/510(K) Number: K163397
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1376.09.031
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/01/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female